FDA's 'Bad Ad' Program Generates One Warning Letter in First Year

Pharma Recipient Says Communal Policing Effort 'Phoniest Thing' Ever

Nearly a year into the Food and Drug Administration's "Bad Ad" program, only one pharmaceutical company has received a warning letter that stemmed from the initiative and the recipient called it a "joke."

The "Bad Ad" program, launched in May 2010 by the FDA's Division of Drug Marketing, Advertising and Communication, enlists the aid of medical professionals and health-care providers to help an understaffed FDA police the pharmaceutical community by anonymously reporting ads and sales pitches that violate FDA rules.

According to the FDA, it has received 239 complaints to the Bad Ad program from its launch in May through January of this year. Of these complaints, 129 (54%) have come from health-care providers, 73 (31%) from consumers, and the remainder from other sources. Of the 239 complaints, approximately 135 were deemed to have sufficient merit for further investigation, with approximately 50% falling within DDMAC oversight and the rest being referred to other centers within FDA.

One of the fears of the Bad Ad plan when it was first announced was that those opposed to direct-to-consumer advertising or competing companies in the same industry could manipulate the program by lodging an anonymous complaint.

Mr. Roth said that's exactly what happened to him. The warning letter, sent to Hill Dermaceuticals on Dec. 3, 2010, was "submitted as a complaint to the DDMAC Bad Ad Program" and stated that certain pages on the company's website are "false or misleading because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product."

"I've been doing this for 40 years and this is the first [warning] letter I ever received from DDMAC," Mr. Roth said. "We believe the complaint was filed by a doctor for another [competing] company."

Mr. Roth said his company's website is the closest thing he has to having an ad budget. "It's a joke," he said. "We don't market off-label. But I sell my products at around $50 a prescription when the average prescription is near $200. So you figure out why they came after me."

Asked why only one warning letter has been generated by the Bad Ad program so far, Robert Dean, a former pharmaceutical sales rep who is now the lead consumer safety officer for DDMAC and helped roll out the program, said DDMAC follows a risk-based approach to enforcement actions.

"All of our enforcement letters undergo a thorough evaluation process to ensure both scientific accuracy and legal sufficiency," Mr. Dean said in an emailed response. "We expect additional letters to issue in the near future."

Mr. Dean added that "DDMAC is pleased with the results of the program to date. It has been well received by the medical community and is proving to be an effective tool to support our public-health mission of stopping misleading promotion."

In a survey last month conducted by pharmaceutical-marketing services company DoctorDirectory, 90% of the nearly 1,000 health-care professionals who responded said they would be "somewhat likely" to report questionable behavior. But only 30% said they were actually aware of the Bad Ad program and only 30% felt absolutely confident that they are qualified to determine what constitutes inappropriate advertising that could be deemed false, misleading or off-label (the latter refers to an advertised claim that the product cures something it's not approved of). And 75% of the respondents also reported that there is potential for abuse by some health-care professionals who may have a bias against, or dislike of, a specific pharma company or representative.

Former FDA Associate Commissioner Peter Pitts, now the president of the Center for Medicine in the Public Interest, said the FDA should be fostering collaboration, "not childish 'gotcha' games."

"The Bad Ad program was a bad idea at conception and has resulted in bad results," he said. "It goes to show that when the FDA tries to earn points by playing cowboys and Indians, the only result is a black eye."

DDMAC says it is premature to characterize the Bad Ad program. The program consists of three phases: the initial rollout last year in which 33,000 health-care providers were informed about the program; Phase 2, which began in January of this year and entails more presentations, including web-based continuing education; and Phase 3, set to launch next year, which calls for upgrades to the website and other yet-to-be-named initiatives.

"Most of the ad complaints by professionals are likely about ads they don't like, not about ads that violate FDA rules," said John Kamp, director of the Coalition for Healthcare Communication. "Thus the program operates much like a complaint box. Some complaints are useful, most are not."